NCT02739568

Pitolisant (BF2.649) in the Treatment of EDS in Patients With OSA

Efficacy and Safety of Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, But Still Complaining of Excessive Daytime Sleepiness

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 389 (actual)
• Sponsor: Bioprojet · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The first objective of this study is to demonstrate the efficacy and safety of pitolisant given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by nCPAP but still complaining of EDS. The secondary objectives of the study include assessing the long-term tolerance as well as the maintenance of efficacy of pitolisant given at 10, 20 or 40 mg per day during 39 weeks of Open Label Extension period and further investigating the co-variates or co-medications that affect the pharmacokinetics of pitolisant in the target population.

Conditions

• Excessive Daytime Sleepiness
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Pitolisant (BF2.649)
DRUG	Placebo

Timeline

• Start date: 2016-04-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2016-04-15
• Last updated: 2020-07-08

Locations

6 sites across 2 countries: Bulgaria, North Macedonia